Mycenax Biotech, Inc.

TAIPEI, Oct. 31, 2025 /PRNewswire/ -- Mycenax Biotech Inc. (TWO:4726), a leading biologics CDMO based in Taiwan, announced the signing of a License Agreement with Japan-based RIN Institute Inc., granting Mycenax rights to apply RIN's proprietary Val-Leu-Lys (VLK) linker technology in CDMO services worldwide. RIN's VLK linker has demonstrated superior anti-tumor efficacy and high serum stability, enabling the development of advanced ADCs. Specifically, the VLK linker facilitates cytotoxicity through two mechanisms: action within the tumor microenvironment and enhanced ADC internalization. The agreement strengthens Mycenax's capability to deliver differentiated ADC solutions for global pharmaceutical partners. "We are thrilled to finalize this agreement with RIN Institute, marking an important milestone in our mission to provide innovative and competitive ADC solutions," said Pei-Jiun Chen, CEO and President of Mycenax. "This collaboration further enhances our technical capabilities and reinforces our commitment to advancing next-generation ADC therapeutics." The partnership builds upon the Letter of Intent (LOI) signed on April 7, 2025, which laid the foundation for closer cooperation between the two companies in advancing ADC innovation. About RIN RIN was established in January 2016, for development of anti-cancer antibody drugs both for therapeutic as well as diagnostic uses based upon the research results by Dr. Yasuhiro Matsumura, Director of Research and former Chief of Division of Developmental Therapeutics, EPOC, National Cancer Center (NCC). In March of the same year, RIN was certified as a spin-out Biotech from NCC. RIN's research laboratory is a research base to promote efficient collaboration with NCC, and R&D projects of ADCs and a novel potent thrombolytic fusion protein have been advanced. In January 2023, RIN started Phase 1 trial of their lead pipeline, a humanized anti-TMEM180 antibody at the NCC. They will accelerate development of new innovative antibodies for anti-cancer drugs and diagnostic drugs with the support of NCC. About Mycenax Mycenax Biotech Inc. is a leading CDMO in Taiwan offering integrated biologics solutions from cell line development to drug product manufacturing. Operating two GMP-compliant facilities inspected and approved by the EMA, PMDA, MFDS, and Health Canada, Mycenax provides end-to-end manufacturing services. Through its partnership with KriSan Biotech and Spera Pharma, Mycenax advances ADC CDMO capability with expertise in site-specific conjugation, multi-arm linkers to meet growing global demand. The company also collaborates with Alfresa Holdings, Kidswell Bio, and Chiome Bioscience under Japan's MHLW subsidy program for biosimilar manufacturing. For more information, visit WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Welcome to Endpoints News ’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Xspray Pharma received a complete response letter for its leukemia treatment Dasynoc over issues found at its third-party contract manufacturer, according to a Wednesday release. No issues were directly related to Dasynoc’s production, but the FDA has paused all approvals related to the site as the manufacturer remedies the issues. Oxford Biomedica has paid $4.5 million to acquire a viral vector manufacturing facility in North Carolina from RTP Operating, which is a subsidiary of National Resilience. Parts of the facility will be operational by the first quarter of next year and Oxford Biomedica will hire additional staffers, it said on Tuesday. Lupin is investing $250 million over the next five years to build a new plant in Coral Springs, FL, the company said Wednesday. The facility will make respiratory medicines and will create 200 new jobs by 2030. API manufacturer Axplora’s investments will exceed €100 million ($116.3 million) across its network this year. This features its €60 million expansion in France, €35 million in Italy and €8.5 million in India, according to a Tuesday release Hello, Ricardo Valdez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Ricardo Valdez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Ricardo Valdez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Ricardo Valdez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Ricardo Valdez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Ricardo Valdez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Ricardo Valdez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Ricardo Valdez. You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Catalent is partnering with Lisata Therapeutics to develop antibody-drug conjugates, they said on Wednesday. Lisata’s certepetide, which is a type of peptide, will be incorporated into Catalent’s ADC technology. Three service providers are working together to offer their manufacturing services. Sai Life Sciences will provide its API services, Agility Life Sciences will bring its formulation development and Centrix Pharma Solutions will offer its drug development and clinical manufacturing, they said on Wednesday. DNA manufacturer UILT Biotechnologies is relocating its headquarters to CvilleBioHub’s facilities at the North Fork Research Park in Charlottesville, VA, it said on Friday. Cell therapy CDMO Kincell Bio is partnering with Moonlight Bio and will provide clinical manufacturing services for Moonlight’s lead T cell therapy candidate, they announced on Tuesday. A joint venture featuring four companies is planning to build a new manufacturing facility in Japan, which will make drug substances and drug products. The four drugmakers – Mycenax Biotech, Alfresa Holdings Corporation, Kidswell Bio Corporation and Chiome Bioscience — are combining all of their biologics manufacturing capabilities, according to a Monday release.

TAIPEI, Sept. 15, 2025 /PRNewswire/ -- Mycenax Biotech Inc. (TWO:4726), a leading biologics CDMO based in Taiwan, today announced strategic alliance with SPERA PHARMA Inc., a Japan-based expert in pharmaceutical Chemistry, Manufacturing, and Controls (CMC). This collaboration brings together the complementary strengths of both companies to deliver a comprehensive solution for antibody-drug conjugates (ADCs) and bioconjugates, covering linker/payload synthesis, drug substance production, formulation, and aseptic fill-finish. The alliance aims to accelerate time-to-market for biopharmaceutical companies by offering an integrated and cost-effective ADC development and manufacturing platform. By leveraging Mycenax's end-to-end biologics capabilities with Krisan Biotech and SPERA PHARMA's CMC expertise — particularly in high-potent fill-finish services for ADCs, the partnership delivers a one-stop solution tailored to the needs of global clients. Founded in 2017 as a spin-off from Takeda Pharmaceutical Company's CMC Research Division, SPERA PHARMA is recognized for its deep experience in complex drug development, including process chemistry, formulation, analytical development, and GMP-compliant aseptic manufacturing. Building on Japan's leading pharmaceutical heritage, SPERA PHARMA is considered one of the country's top CDMOs, trusted by global partners for its technical excellence and integrated CMC solutions. Mycenax is a global biologics CDMO audited by international regulatory agencies including EMA, PMDA, and Health Canada. Its 2022 strategic partnership with KriSan Biotech further expanded its next-generation ADC technology platform. Together, Mycenax and SPERA PHARMA offer an end-to-end development and manufacturing solution. This empowers global ADC developers with speed, flexibility, and technical excellence. About SPERA PHARMA SPERA PHARMA, founded in July 2017 in Osaka, Japan, is a contract development and manufacturing organization (CDMO) specializing in Chemistry, Manufacturing and Controls (CMC). Its expertise spans process chemistry, formulation development, analytical sciences, and GMP-compliant manufacturing of investigational drugs. Backed by a team of highly experienced researchers with a strong track record, SPERA PHARMA provides flexible support across all phases of pharmaceutical development from early research to regulatory approval. As a one-stop provider of comprehensive CMC solutions, the company is committed to meeting the diverse needs of global clients. For further information, please visit spera-pharma.co.jp/en About Mycenax Mycenax, a Taiwan-based CDMO, delivers integrated biologics solutions from process development to cGMP-compliant manufacturing. With two GMP-compliant manufacturing facilities and a strategic partnership with KriSan Biotech, Mycenax is committed to developing and manufacturing ADC therapeutics for the global market. For further information, please visit WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED